Validating chromatographic methods

Posted by / 07-Mar-2018 15:00

Validating chromatographic methods

These are critical components of a quality management system such as ISO 9000.The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. The PMBOK guide, a standard adopted by IEEE, defines them as follows in its 4th edition: In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service or system, then performing a review or analysis of the modeling results.A set of validation requirements (as defined by the user), specifications, and regulations may then be used as a basis for qualifying a development flow or verification flow for a product, service, or system (or portion thereof, or set thereof).Additional validation procedures also include those that are designed specifically to ensure that modifications made to an existing qualified development flow or verification flow will have the effect of producing a product, service, or system (or portion thereof, or set thereof) that meets the initial design requirements, specifications, and regulations; these validations help to keep the flow qualified.

These terms generally apply broadly across industries and institutions.

Validation work can generally be categorized by the following functions: In GLP accredited laboratories, verification/revalidation will even be conducted very often against the monographs of the Ph.

Eur., IP to cater for multinational needs or USP and BP etc to cater for national needs.

When machinery/equipment qualification is conducted by a standard endorsed third party such as by an ISO standard accredited company for a particular division, the process is called certification.

Currently, the coverage of ISO/IEC 15408 certification by an ISO/IEC 27001 accredited organization is limited; the scheme requires a fair amount of efforts to get popularized.

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It is a process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements.